A DDI Study to Investigate PK and Safety of Cefiderocol in Combination With Xeruborbactam in Healthy Adult Participants

Phase 1

Recruiting

• Conditions: Bacterial Infections
• Interventions: Drug: Dextrose 5% in water; Drug: Xeruborbactam; Drug: Cefiderocol; Drug: Xeruborbactam/Cefiderocol

• Registration Number: NCT06547554
• Lead Sponsor: Qpex Biopharma, Inc.

Brief Summary

A phase 1, randomized, double blind, placebo controlled drug-drug interaction, pharmacokinetics and safety study of cefiderocol in combination with xeruborbactam in healthy adult participants

Detailed Description

Qpex Biopharma, Inc. is developing xeruborbactam, a new boron-based beta-lactamase inhibitor with activity against both serine and metallo-beta-lactamases in combination with a beta-lactam antibiotic.

Cefiderocol is a cephalosporin antibiotic approved in the US for the treatment of complicated urinary tract infections including pyelonephritis, and hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia.

Study Timeline

• Study First Submitted: 2024-08-02
• Study First Submitted QC: 2024-08-07
• Study First Posted: 2024-08-09
• Study Start: 2024-09-04
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-23
• Last Update Posted: 2025-02-25
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Male or female, 18 to 55 years of age (inclusive) at the time of signing the informed consent.
• Body mass index (BMI) ≥ 18.5 and 32 (kg/m2) and weight between 55.0 and 100.0 kg (inclusive)
• Subjects must be judged to be in good health based upon the results of a medical history, physical examination, vital signs, 12-lead electrocardiogram and laboratory profile
• Voluntary consent to participate in the study.

Exclusion Criteria

• History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
• A subject with active drug or alcohol abuse within 2 years prior to the initial study drug administration
• Females who are pregnant or lactating
• Documented hypersensitivity reaction or anaphylaxis to any medication. History of any severe hypersensitivity, anaphylaxis, or allergic reaction to cefiderocol or any other beta-lactam antibacterial drugs, or any other excipients used in the formulation (eg, cephalosporins, penicillins, carbapenems, or monobactams)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Single Dose Cohorts Placebo	Dextrose 5% in water	5% Dextrose in water
Single Dose Cohorts	Xeruborbactam	Administered single fixed dose of Xeruborbactam Administered single fixed dose of Cefiderocol Administered single fixed dose of a combination of Xeruborbactam and Cefiderocol.
Single Dose Cohorts	Xeruborbactam/Cefiderocol	Administered single fixed dose of Xeruborbactam Administered single fixed dose of Cefiderocol Administered single fixed dose of a combination of Xeruborbactam and Cefiderocol.
Single Dose Cohorts	Cefiderocol	Administered single fixed dose of Xeruborbactam Administered single fixed dose of Cefiderocol Administered single fixed dose of a combination of Xeruborbactam and Cefiderocol.

Primary Outcome Measures

Name	Time	Method
Area under the plasma concentration versus time curve (AUC) between cohorts	17 days	Comparison will be performed between the groups for area under the plasma concentration versus time curve (AUC) Mean graphical presentation of the data will be reported. Statistical analysis of exposure parameters will be performed.
Peak plasma Concentration measurements by subject and by cohort (Cmax)	17 days	Comparison will be performed between the groups for concentration measurements (Cmax). Mean graphical presentation of the data will be reported.
Urine Pharmacokinetic (PK) amount excreted by subject and by cohort	17 days	Urine Pharmacokinetic (PK) parameters such as amount excreted will be calculated from urinary excretion data.
Urine Pharmacokinetic (PK) % dose excreted by subject and by cohort	17 days	Urine Pharmacokinetic (PK) parameters such as amount of % dose excreted will be calculated from urinary excretion data.
The incidence and nature of treatment emergent adverse events (TEAE)	17 days	Number of patients with Treatment-Emergent Adverse Events by subject, by group, severity and relationship to treatment.
Number of patients with changes from baseline in safety parameters	17 days	Number of patients with changes in safety parameters before and after dosing by subject and group.
Time concentration data measurements by subject and by cohort (Tmax)	17 days	Comparison will be performed between the groups for time concentration data measurements (Tmax).

Trial Locations

Locations (1)

Minneapolis Clinic; 🇺🇸 Minneapolis, Minnesota, United States